Many prescription and over-the-counter medicines (a.k.a., drugs) require adherence to a specific dosing regimen (i.e., dosing-regimen compliance) that dictates the amount of medicine administered (i.e., dosage) each time it is provided to a user, the frequency with which it is administered to the user (dosing interval), and a recommended time frame around each dosing interval (dosing window) in which the medicine should be administered to the user. Unfortunately, dosing-regimen noncompliance is common and leads to a costly problem in many ways, from driving up health care costs to financial losses to the pharmaceutical industry to serious negative human impacts:                125,000 people die in the US each year as a result of failure to adhere to dosing regimens for prescription drugs;        Studies reflect $290 billion per year of healthcare implications of dosing-regimen non-compliance;        The global pharmaceutical market loses an estimated $564 billion annually, or 59% of the $956 billion in total global pharmaceutical revenue in 2011 due to dosing-regimen non-compliance;        In developed countries, adherence to long-term therapies in the general population is around 50%, and much lower in developing countries; and        Nearly three out of four Americans are not taking their medications as directed—which results in serious health consequences, especially for people with chronic diseases.        
The need to properly follow a dosing regimen for a prescription drug is particularly acute for oral contraceptive pills (OCP). For example, in addition to the above issues, failure to follow the proper dosing regimen for OCP has already led to countless unwanted pregnancies and could lead to many more. OCP is one of the most popular forms of contraception, particularly among young women. A government report published Oct. 18, 2012 provides the following statistics for the U.S.:                Sixty-two percent of women of reproductive age are currently using contraception. Of women using a contraceptive method in the month of the interview, the most common methods used are the pill (28%, or 10.6 million women) and female sterilization (27%, or 10.2 million women). Use of intrauterine devices as a current method has increased since 1995 (from 0.8% in 1995 to 5.6% in 2006-2010), whereas fewer women report that their partners are using condoms as their current, most effective contraceptive method. Of women at risk of an unintended pregnancy, 11% report not currently using a method of contraception.        
A United Nations report published in 2011 provides the follow statistics worldwide:                In developed countries as a whole, the most commonly used methods are the pill (used by 18 percent of women of reproductive age who are married or in a union) and the male condom (with 18 percent prevalence). Those two methods accounted for half of all contraceptive use in the developed countries. By contrast, in developing countries the methods with the highest prevalence were female sterilization (21 percent) and the IUD (15 percent), accounting together for 58 percent of overall contraceptive use.        
Failure to take a pill is one of the main reasons for seeking emergency contraception (e.g., the morning after pill) in women relying on OCP. A primary cause of unintended pregnancy in these women may therefore be poor dosing-regimen compliance. Studies suggest that as much as 47% of women worldwide show poor adherence to the prescribed dosing regimen, missing two or more pills per cycle. (A menstrual cycle is on average 28 days.) Britain's largest manufacturer of OCP, Schering Health Care Ltd, reports that on average women forget to take their pill eight times a year. Most know they have to take remedial steps when they miss a pill, but few know what. Only 10% know missing just one pill places them at risk of pregnancy.
The success of OCP is tightly coupled to adherence to its prescribed dosing regimen, i.e., taking the right pill on the right day during a woman's menstrual cycle. For this reason, birth control pills are packaged in blister cards on which a calendar is printed to guide the patient on which pill to take on which day. Furthermore, the recommended dosing interval, from day to day, is 24 hours and each days dose should be taken within the same time frame within the day. In other words, each day includes a recommended dosing window. For this reason, many use daily reminders (e.g., on mobile devices) to help stay compliant. When a patient becomes non-compliant, the manufacturer recommends specific steps to regain compliance and reduce chances of unintended pregnancy in the interim. Unfortunately, the recommended mediation approaches are not always followed correctly, leading to higher risk of unwanted pregnancy.
A packaging approach that provides one or more of improved patient adherence/compliance, treatment results, authentication, and packaging and distribution approaches would be a welcome advance for the pharmaceutical industry and have particular benefit in the realm of OCP dosing-regimen compliance, as well as dosing regimens for other prescription or over-the-counter drugs.